American Heart Journal
Volume 152, Issue 3 , Pages 407-409 , September 2006

Reflections on early stopping of a clinical trial

  • Paul W. Armstrong, MD

      Affiliations

    • University of Alberta, Edmonton, Alberta, Canada
    • Corresponding Author InformationReprint requests: Paul W. Armstrong, MD, 2-51 Medical Sciences Bldg, University of Alberta, Edmonton, Alberta, Canada T6G 2H7.
    • ,
  • Christopher B. Granger, MD

      Affiliations

    • Duke Clinical Research Institute, Durham, NC

Received 14 June 2006 ,Accepted 16 June 2006.

References 

  1. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration—a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363–1364
  2. Topol EJ. Arthritis medicines and cardiovascular events—“House of Coxibs”. JAMA. 2005;293:366–368
  3. Lievre M, Menard J, Bruckert E, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety or feasibility. BMJ. 2001;322:603–605
  4. Illtis AS. Stopping trials early for commercial reasons: the risk-benefit relationship as a moral compass. J Med Ethics. 2005;31:410–414
  5. Psaty BM, Drummond R. Stopping medical research to save money—a broken pact with researchers and patients. JAMA. 2003;289:2128–2130
  6. Armstrong PW, Adams PX, Al-Khalidi HR, et al. on behalf of the APEX-AMI Steering Committee Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI). A multicenter, randomized, double-blind parallel-group placebo-controlled study of pexelizumab in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention. Am Heart J. 2005;149:402–407
  7. Press release—Alexion reports phase III results for PRIMO-CABG2 study. http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104andSTORY=/www/story/11-23-2005/0004222006&EDATE(accessed May 2006)
  8. Mahaffey K, Van de Werf F, Shernan S, et al. Effect of pexelizumab on mortality in patients with acute myocardial infarction or undergoing coronary artery bypass surgery: a systematic overview. AHJ (In press).
  9. Black HR, Elliott WJ, Grandits G, et al. for the CONVINCE Research Group Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) Trial. JAMA. 2003;289:2073–2082
  10. The GUSTO Investigators . An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993;329:673–682

 Conflict of Interest: Dr Paul Armstrong and Dr Christopher Granger are in receipt of research grants from Procter & Gamble Pharmaceuticals, Cincinnati, OH, and Alexion Pharmaceuticals, Cheshire, CT.

PII: S0002-8703(06)00554-0

doi: 10.1016/j.ahj.2006.06.006

American Heart Journal
Volume 152, Issue 3 , Pages 407-409 , September 2006

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